| Date Initiated by Firm | June 24, 2022 |
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| Date Posted | August 05, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1502-2022 |
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| Recall Event ID |
90548 |
| 510(K)Number | K193269 |
|---|
| Product Classification |
Implantable transprostatic tissue retractor system - Product Code PEW
|
| Product | UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool |
|---|
| Code Information |
UDI/DI: 00814932020049 & 00814932020001; Lot #s: 73M2100393 73A2200670 73M2100394 73A2200671 73M2100395 73A2200672 73A2200012 73A2200673 73A2200013 73A2200674 73A2200014 73A2200832 73A2200221 73A2200841 73A2200222 73A2200859 73A2200223 73A2200905 73A2200224 73B2200116 73A2200225 73B2200466 73A2200226 73C2200567 73A2200473 New Lots added as of 08/01/2022: 73A2200834, 73C2200911, and 73C2201163 |
| FEI Number |
3005791775
|
Recalling Firm/
Manufacturer |
Neotract Inc
4155 Hopyard Rd
Pleasanton CA 94588-8534
|
| For Additional Information Contact | Customer Service
866-396-2111 |
|---|
Manufacturer Reason
for Recall | There is the potential that during implant deployment, the device may not properly deliver a implant. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
|---|
| Action | Between the dates of June 28-29, 2022, NeoTract, Inc. (a subsidiary of Teleflex Inc.) issued a "Urgent Medical Device Recall" notification to affected consignees via UPS. On July 29,2022 NeoTract, Inc. sent an updated recall notification for additional lots that were affected. NeoTract asked consignees to take the following actions:
1. If you have affected stock:
a. Immediately discontinue use and quarantine any products with the lot numbers listed
above, so that the affected products can be returned to Teleflex. Lot numbers are printed
on the product shelf carton and Tyvek labels (refer to attached appendix demonstrating
how you can locate the lot numbers and part catalog numbers for these products)
b. Please return the affected products as follows as soon as possible:
c. Complete the enclosed Recall Acknowledgement Form and email back to
uroliftrecall@teleflex.com.
This will allow us to document the number of affected products you have on hand for
return. A customer service representative will issue you a Return Goods Authorization
(RGA) Number and will provide instructions for returning the products to Teleflex.
d. Attach the RGA Number to the affected product and follow the shipping instructions
provided by Teleflex customer service.
2. If you have no affected stock:
a. Please complete the enclosed Recall Acknowledgement Form and email back to
uroliftrecall@teleflex.com. This will allow us to document your receipt of this letter.
3. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service at (866) 396-2111 or may also be reported to the FDA s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm, by fax to 1-800-FDA (332)-0178 or by phone, 1-
800-FDA (332)-1088. |
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| Quantity in Commerce | 18,722 systems |
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| Distribution | US: AK AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NY OH OK PA RI SC SD TN TX UT VA VT WI WV
OUS: None |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = PEW
|
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